SILHOUETTE FC— 510(k) K993090
Substantially EquivalentGe Medical Systems, Inc.
FDA 510(k) clearance K993090 for SILHOUETTE FC, Substantially Equivalent on 1999-10-01. Applicant: Ge Medical Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Ge Medical Systems, Inc.
- Product code
- Code KPR
- Device class
- Class 2
- Regulation
- 21 CFR 892.1680
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Waukesha, WI, US
Recent devices under product code KPR
view allMore clearances from Ge Medical Systems, Inc.
view all- K091673 — GE LIGHTSPEED ACT FP16
- K082104 — GE LIGHTSPEED RT16 / LIGHTSPEED XTRA V2 CT SYSTEM (AKA GE LIGHTSPEED RT16 / LIGHTSPEED XTRA CT SYSTEM
- K042844 — GE SIGNA EXCITE 1.5T 6 CHANNEL PHASED ARRAY FLEX COIL, GE SIGNA EXCITE 3.0T 6 CHANNEL PHASED ARRAY FLEX COIL
- K042053 — INNOVA 4100, INNOVA 3100
- K040125 — SENOGRAPHIC STEREO
Adverse events under product code KPR
product code KPR- Other
- 6
- Total
- 6
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K993090
K-number listed on FDA's recall record- Z-0550-2025 — GE Proteus XR/A radiographic system
- Z-2733-2024 — GE Healthcare Proteus XR/a, stationary X-Ray System, Model/Catalog Numbers: 1) 2259973; 2) 2259988; 3) 2266999; 4) 2373519; 5) 2379827; 6) 5729352; 7) 2259973-1; 8) 2259973-2; 9) 2259973-3; 10) 2259973-4; 11) Not Available
- Z-2449-2019 — Proteus XR/a (SlOK : K993090)
- Z-1752-2019 — Proteus XR/a The Proteus XR/a radiographic system offers the flexibility to choose a configuration based upon your specific requirements. The system provides exceptional image quality, high frequency X-ray generation, easy patient positioning, intuitive operator control and minimal system maintenance.
- Z-1248-2015 — GE Healthcare Proteus XR/a with wall stand model number 2260354. Intended for use in generating radiographic images of human anatomy in all general purpose diagnostic procedures. This device is not intended for mammographic applications.
- Z-0954-2015 — GE Healthcare, Proteus XR/a with wall stand model number 600-0301.
- Z-1988-2014 — GE Healthcare, Proteus XR/a. Proteus XR/a Intended Use: Is intended for use in generating radiographic images of human anatomy in all general purpose diagnostic procedures. This device is not intended for mammographic applications.
- Z-1790-2012 — GE Proteus XR/a Radiographic System. GE Medical Systems-Americas Milwaukee, WI. Model Number: 2259988. Product is indicated for use in generating radiographic images of human anatomy in all general-purpose diagnostic procedures. This device is not intended for mammographic applications.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K993090.
Data sourced from openFDA. This site is unofficial and independent of the FDA.